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The Role of Colchicine in Preventing Atherosclerotic Cardiovascular Disease in Type 2 Diabetes (Col-DM Study)

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
SUMMARY

This study will test whether a low-cost anti-inflammatory medicine called colchicine can help protect the blood vessels of people with type 2 diabetes. Diabetes speeds up hardening of the arteries (atherosclerosis), partly because of ongoing low-grade inflammation. Colchicine has already been shown to help prevent heart attacks and strokes in people who already have heart disease; this study looks at whether it can also help prevent early blood vessel damage before heart disease develops. Around 300 adults with type 2 diabetes will be randomly assigned to take colchicine or a placebo (dummy pill) once daily for 24 weeks, in addition to their usual diabetes and heart-risk medications. Neither participants nor the study team will know who is taking colchicine or placebo. The main measurement will be the change in the thickness of the wall of the neck (carotid) artery, measured by ultrasound, which is an early sign of blood vessel disease. The study will also look at markers of inflammation in the blood, blood vessel stiffness and function, and changes in the gut bacteria.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 21
Maximum Age: 80
Healthy Volunteers: f
View:

• T2DM on stable diabetes medications (no change in last 3 months)

• At least one other comorbidity of hypertension, dyslipidaemia and/or obesity (BMI ≥27), with no previous history of ASCVD

• Able to provide informed consent

Locations
Other Locations
Singapore
Tan Tock Seng Hospital
RECRUITING
Singapore
Contact Information
Primary
Sanchalika Acharyya, PhD, MPH
sanchalika.acharyya@nhghealth.com.sg
96150202
Backup
Shirley Lin Shangmei
ttsh.p2p.research@nhghealth.com.sg
Time Frame
Start Date: 2025-07-24
Estimated Completion Date: 2027-07-31
Participants
Target number of participants: 300
Treatments
Experimental: Colchicine
Colchicine 0.5 mg orally once daily for 24 weeks, in addition to usual risk-factor-based therapy
Placebo_comparator: Placebo
Matched placebo orally once daily for 24 weeks, in addition to usual risk-factor-based therapy
Sponsors
Collaborators: Nanyang Technological University
Leads: Tan Tock Seng Hospital

This content was sourced from clinicaltrials.gov